SCDM Releases Trends Impacting Clinical Data Management
The Society for Clinical Data Management, SCDM, has released its latest Reflection Paper, “The Evolution of Clinical Data Management to Data Science.” Patrick Nadolny, Chair of the SCDM Innovation Committee and Global Head of Clinical Data Management and Programming at Allergan noted the goal of the paper is to provide a “forward-looking and pragmatic view on why and how emerging study designs, regulations, and technology innovations are reshaping the role and profile of clinical data management. ”
Highlights include: [Link to paper here]
- The impact of the rising complexity of clinical research approaches such as adaptive study design and decentralized clinical trials
- What a continually shifting regulatory environment means for data quality and clinical data management practices, including definitions of data quality and riskâbased clinical data management.
- How new technologies such as Artificial Intelligence (AI) and wearable are transforming clinical trials leading to the reduction of electronic data capture (EDC) centricity moving forward
- Career considerations for clinical data managers – among them how the role of the clinical data manager is changing, why clinical data management is at the heart of riskâbased study execution, and new skillsets necessary for managing the evolution of clinical data.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
